New article and content23 Apr 2018 15:05
ImmuPharma chairman and chief executive upbeat on Lupuzor; industry interest remains strong
http://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html
11:18 23 Apr 2018
In some cases, where patients possessed certain biomarkers, the response was statistically significant; indeed a small handful of patients went into full remission. The plan now is to take a deep dive into the data. Then there are also conversations to be had with the regulators, who are likely to be a little more understanding than investors who bailed out. �We need to have a discussion with the FDA [Food & Drug Administration] and EMA [European Medicines Agency] to see what they think because there have been trials where the end-point strictly speaking wasn�t met but the FDA understands what�s good for the patient and they understand context,� said CEO Dimitriou. �You could have an optimistic scenario where you have conditional approval to make it [Lupuzor] freely available for the patient without having the formal approval. That�s the discussion to be had.�
At the same time, talks with potential industry partners are ongoing, with more than ten having signed non-disclosure agreements with ImmuPharma. The latest results don�t appear to have rattled potential collaborators. �We sent them the top-line numbers to the people who we signed confidentiality agreements with. A lot came back the same day and some that didn�t have CDAs [confidentiality agreements] in place sent through CDAs the same day,� said Dimitriou.
McCarthy added: �The message to take away is we have done an awful lot of groundwork with these companies before we got these results. Within 48 hours we have shared the data and already had responses back.� Agreeing a licensing deal traditionally takes around a year, though the competition can be a catalyst. And remember, Lupuzor has already been through the validation process having earlier in its history been licensed to Cephalon before the takeover of the US biotech saw the rights handed back.
But just why would big pharma be interested in Lupuzor? Well, lupus sufferers, of which there are around 5mln worldwide, are incredibly poorly served. The standard treatment is steroid-based, which has many side-effects, while the GlaxoSmithKline-made Benlysta, the first drug in the space for 50 years, also has significant drawbacks. This and the cost of Benlysta means that probably no more than around 13,000 patients have been treated.
A side-effect free alternative? Even with that limited group, the GSK drug generated US$400mln of revenues. Imagine if you could get a side-effect-free alternative to market. One would assume the take-up rate would be much higher. �Lupuzor is still a potential multi-billion dollar selling drug. The trial hasn�t